接受新一代药物洗脱支架介入治疗的高动脉血栓形成风险与低动脉血栓形成风险的患者：来自随机 BIOFLOW 试验的分析。
Patients with higher-atherothrombotic risk vs. lower-atherothrombotic risk undergoing coronary intervention with newer-generation drug-eluting stents: an analysis from the randomized BIOFLOW trials.
机构信息
Division of Cardiology, Department of Internal Medicine II, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.
Heart Center Bad Segeberg, Segeberger Kliniken GmbH, Bad Segeberg, Germany.
出版信息
Clin Res Cardiol. 2023 Sep;112(9):1278-1287. doi: 10.1007/s00392-023-02205-4. Epub 2023 Apr 16.
BACKGROUND
Patients with atherothrombotic risk are at high hazard of ischemic events. Preventive medicine plays a major role in modifying their outcomes. Whether the choice of a BP-SES or DP-EES can contribute to the occurrence of events remains unclear. We sought to investigate the outcomes of patients with higher atherothrombotic risk (H-ATR) versus lower atherothrombotic risk (L-ATR) undergoing percutaneous coronary intervention (PCI) with either bioresorbable-polymer sirolimus-eluting stent (BP-SES) or durable-polymer everolimus-eluting stent (DP-EES).
METHODS
Patients (n = 2361) from BIOFLOW-II, -IV, and -V randomized trials were categorized into H-ATR vs. L-ATR. L-ATR patients had ≤ 1 and H-ATR ≥ 2 of the following criteria: presentation in ACS, diabetes mellitus, previous myocardial infarction, previous PCI/CABG, or previous stroke. Endpoints were target lesion failure (TLF: cardiac death, target-vessel myocardial infarction [TV-MI], target lesion revascularization [TLR]) and stent thrombosis (ST) at three years.
RESULTS
H-ATR patients (n = 1023) were more morbid than L-ATR patients (n = 1338). TLF rate was significantly higher in H-ATR patients as compared with L-ATR (11.6% vs. 7.0%; HR 1.67, 95% CI 1.27-2.20, p < 0.0001). With BP-SES TLF rates were numerically lower as compared with DP-EES in H-ATR (10.5% vs. 13.5%; HR 0.78, 95% CI 0.54-1.14, p = 0.20) and significantly lower in L-ATR (5.6% vs. 9.8%; HR 0.57, 95% CI 0.38-0.85, p = 0.006).
CONCLUSION
In the era of newer-generation DES, patients with H-ATR still are at hazard for ischemic events. Patients with BP-SES had lower TLF rates as compared with DP-EES, most consistent in L-ATR whereas in H-ATR patients most probably secondary preventive strategies are of higher value.
CLINICAL TRIAL REGISTRATION
Clinicaltrial.gov. NCT01356888, NCT01939249, NCT02389946. https://clinicaltrials.gov/show/NCT01356888 , https://clinicaltrials.gov/show/NCT01939249 , https://clinicaltrials.gov/show/NCT02389946 .
背景
患有动脉血栓形成风险的患者发生缺血事件的风险很高。预防医学在改变他们的预后方面起着重要作用。使用生物可吸收聚合物西罗莫司洗脱支架（BP-SES）或耐用聚合物依维莫司洗脱支架（DP-EES）是否会导致事件发生仍不清楚。我们旨在研究更高动脉血栓形成风险（H-ATR）与较低动脉血栓形成风险（L-ATR）的患者接受经皮冠状动脉介入治疗（PCI）时的结局，这些患者分别使用生物可吸收聚合物西罗莫司洗脱支架（BP-SES）或耐用聚合物依维莫司洗脱支架（DP-EES）。
方法
来自 BIOFLOW-II、-IV 和 -V 随机试验的患者（n=2361）被分为 H-ATR 与 L-ATR。L-ATR 患者符合以下标准中的≤1 个：ACS 发作、糖尿病、既往心肌梗死、既往 PCI/CABG 或既往中风。终点为靶病变失败（TLF：心脏死亡、靶血管心肌梗死[TV-MI]、靶病变血运重建[TLR]）和支架血栓形成（ST）三年。
结果
H-ATR 患者（n=1023）比 L-ATR 患者（n=1338）病情更严重。与 L-ATR 患者相比，H-ATR 患者的 TLF 发生率显著更高（11.6% vs. 7.0%；HR 1.67，95%CI 1.27-2.20，p<0.0001）。与 DP-EES 相比，H-ATR 患者使用 BP-SES 的 TLF 发生率略低（10.5% vs. 13.5%；HR 0.78，95%CI 0.54-1.14，p=0.20），在 L-ATR 中则显著更低（5.6% vs. 9.8%；HR 0.57，95%CI 0.38-0.85，p=0.006）。
结论
在新一代 DES 时代，H-ATR 患者仍面临缺血事件的风险。与 DP-EES 相比，BP-SES 患者的 TLF 发生率更低，在 L-ATR 中更为一致，而在 H-ATR 患者中，二级预防策略可能更有价值。
临床试验注册
Clinicaltrial.gov。NCT01356888、NCT01939249、NCT02389946。https://clinicaltrials.gov/show/NCT01356888、https://clinicaltrials.gov/show/NCT01939249、https://clinicaltrials.gov/show/NCT02389946。
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